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Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease (SCD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Jennifer Burgis, Stanford University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01749813
First Posted: December 17, 2012
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Burgis, Stanford University
  Purpose
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.

Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Jennifer Burgis, Stanford University:

Primary Outcome Measures:
  • Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease [ Time Frame: 1 year ]
    The primary end point of the study is the proportion of patients achieving steroid free remission at 6 months


Biospecimen Retention:   Samples With DNA
Blood and stool

Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Patients will be seen in clinic at new diagnosis of Crohn's disease or a flare of existing disease. Potential subjects will be screened with for eligibility, followed by a baseline assessment by the clinic provider. Subjects who wish to participate will undergo further discussion with one of the study staff. At enrollment, a member of the study staff will explain the study to the prospective participant (for consent and/or assent, if applicable given patient's age).

The SCD will be started in addition to previous maintenance medication therapy or with short course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). Steroid induction based on clinical need.

We anticipate improvement in clinical symptoms, laboratory values and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients) after 4 weeks. Patients who do not reach remission by 4 weeks will be excluded from the study. Patients who require additional medications for disease control will be excluded from the study.

Patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1 month, 3 months and 6 months.

Assessment at initial enrollment and at all follow-up visits includes:

  1. History of symptoms
  2. Physical exam including height, weight, BMI, Tanner staging
  3. Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
  4. Dietary assessment and nutritional counseling
  5. Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
  6. Adverse event monitoring (record of symptoms and review of laboratory surveillance)
  7. Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
  8. Serum sample for cytokine studies
  9. Stool studies for microbiota studies
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children under 18 Adult
Criteria

Inclusion Criteria:

  • Adult or pediatric patients presenting with a new diagnosis or flare of existing Crohn's disease based on standard diagnostic criteria including: clinical symptoms, laboratory parameters, disease activity indices (Pediatric Crohn's Disease Activity Index (PCDAI) for patients <19years and Crohn's Disease Activity Index (CDAI) for patients >19years), pathology from upper endoscopy/colonoscopy and imaging studies.

Exclusion Criteria:)

  • Pregnancy
  • Other autoimmune conditions including celiac disease, rheumatoid arthritis, multiple sclerosis
  • Otherwise immunosuppressed patients including HIV and prior organ transplant
  • Patients diagnosed with ulcerative colitis or indeterminate colitis
  • Active tuberculosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749813


Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ken Cox, MD Stanford University Medical
Principal Investigator: Shamita Shah, MD Stanford University Medicial
Principal Investigator: Jennifer Burgis, MD Stanford University Medical
  More Information

Additional Information:
Responsible Party: Jennifer Burgis, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01749813     History of Changes
Other Study ID Numbers: 23031
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by Jennifer Burgis, Stanford University:
Carbohydrate Specific Diet
Crohn's Disease
Immunomodulators

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases